APA Warns of Dangers In Rush to E-Prescribe
Federal standards for electronic prescribing (e-prescribing) proposed by the Centers for Medicare and Medicaid Services (CMS) must be pilot tested first, APA informed CMS Administrator Mark McClellan, M.D., M.P.H., in a recent letter. Further, the deadline for compliance with the standards should be moved from January 1, 2006, to the end of 2007.
Those are just a two of the recommendations expressed in a lengthy comment letter signed by APA Medical Director James H. Scully, M.D., regarding the agency's proposed final standards for e-prescribing.
The proposed e-prescribing regulations, issued at the beginning of the year, are intended to hasten the adoption of e-prescribing by physicians. The effort is part of a global effort to move medicine toward electronic medical record keeping.
The regulations would establish standards for the following:
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Transactions between prescribers and dispensers for new prescriptions, prescription refill requests and responses, prescription change requests and responses, prescription cancellation requests and responses, and related messaging and administrative transactions.
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Eligibility and benefit inquiries and responses between drug prescribers and prescription drug plans.
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Eligibility and benefit inquiries and responses between dispensers and sponsors of the new Medicare prescription drug benefit under Part D.
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Formulary and benefit coverage information, including information on the availability of lower-cost, therapeutically appropriate alternative drugs, if certain characteristics are met.
Under the Medicare Modernization Act of 2003 (MMA), the National Committee on Vital and Health Statistics (NCVHS) was called upon to develop recommendations to CMS for uniform standards for e-prescribing. From March to September 2004, NCVHS heard testimony from 65 witnesses and industry experts including all stakeholder groups identified in the MMA, as well as e-prescribing networks, demonstration projects, software developers, and consumer advocacy organizations.
The proposed e-prescribing foundation standards are based on the NCVHS's recommendations to McClellan.
The letter from Scully outlined a series of concerns about the proposal focused on protection of patient privacy, the need to minimize the cost burden associated with acquiring technology for e-prescribing, development of regulations to protect physicians who accept in-kind technological assistance for e-prescribing, and policies to protect against manipulation of physician prescribing choices.
All of these concerns found expression in Scully's request that CMS reconsider the deadline for compliance and pilot test the standards in a subgroup of physicians before adopting them as final standards.
“APA maintains that the goals and mission of effectuating widespread adoption of e-prescribing with the physician community will be fraught with barriers, unless CMS adopts a more judicious, cautious approach,” Scully wrote. “Pilot-testing of standards within their actual context of usage is imperative, along with a more realistic, workable effective date for e-prescribing compliance....
“Only after evaluating the results of e-prescribing pilot projects using different systems across a spectrum of clinical settings will it be feasible to determine precisely which standards, process areas, or technologies require adjustment. It will take some time to discover how to perfect these systems, and CMS must not foreshorten this process or it will prove ultimately to be at the expense of patients.”
Specifically, APA urges CMS to take these actions:
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Work with the Office of the Inspector General to draft a new “safe harbor” regulation for physicians to accept nonmonetary assistance freely to implement their e-prescribing infrastructure and to establish an effective temporary exemption from prosecution under the “Stark II” federal law. (That law regulates transactions between physicians and various other designated health services and entities).
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Establish clear policies prohibiting design bias in software and hardware for e-prescribing systems, as well as for streaming commercials and other superfluous information into e-prescribing systems.
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Adopt proposed standards as initial, rather than final, to determine their functionality and interoperability and pilot test all initial standards, preferably using several technology systems for comparative data.
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Move the effective date for e-prescribing rules to the end of 2007 to ease the burden of the transition into Medicare Part D of those beneficiaries who are “dually eligible” for Medicare and Medicaid. This will provide more time to issue national prescriber identifier numbers for physicians to obtain and implement grants and to finalize new laws protecting physicians from prosecution for accepting assistance with e-prescribing systems.
The CMS standards are posted online at<www.cms.hhs.gov/medicarereform/E-Prescribing.pdf>. The text of APA's comments to CMS is posted at<www.psych.org/members/advocacy_policy/reg_comments/APACommentsERxg.pdf>.▪
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Published online: 19 August 2005
Published in print: August 19, 2005
Notes
Adoption of e-prescribing by the physician community will be fraught with barriers unless CMS adopts a more cautious approach, according to APA Medical Director James H. Scully Jr., M.D.
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